Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Locally advanced or metastatic disease

• Incurable disease

• Tumor accessible for biopsy

• Prior breast cancer allowed

• No symptomatic or untreated brain metastases or carcinomatous meningitis

• Neurologically stable patients with inactive brain metastases are allowed if off corticosteroids for at least 4 weeks prior to study

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal

• ALT/AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• LVEF at least 40%

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Ophthalmic:

• No prior abnormalities of the cornea, including:

• Dry eye syndrome or Sjogren's syndrome

• Congenital abnormality (e.g., Fuch's dystrophy)

• Abnormal slit-lamp examination with a vital dye (e.g., fluorescein or Bengal-Rose)

• Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)

• No concurrent use of contact lenses

Other:

• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (e.g., gefitinib or other anilinoquinazolines)

• No other concurrent uncontrolled illness

• No active infection

• No uncontrolled diabetes mellitus

• No psychiatric illness or social situation that would preclude study

• No untreated life-threatening disease

• No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

• Weight less than 136 kg

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics

• At least 2 weeks since prior hormonal therapy

• No concurrent hormonal therapy

Radiotherapy:

• At least 3 weeks since prior radiotherapy

• No concurrent radiotherapy except localized external beam radiotherapy for palliative treatment of metastatic disease (cannot include significant cardiac muscle within the radiotherapy field)

Surgery:

• Not specified

Other:

• No other concurrent investigational anticancer agents